Thursday, April 28, 2016
GE Healthcare’s life sciences business has officially launched a new research scheme to help foster Turkish bioprocessing development and manufacturing, through its latest Fast Trak Bioprocessing Technology and Training Laboratory in Istanbul. Based in GE’s Turkey Innovation Center, the R&D Laboratory is well-located to support the region’s rapidly growing biopharmaceutical and biotech industry, and help position Turkey as a global R&D and manufacturing hub.
Civil servants must observe a period of “purdah” in the weeks before a general election or referendum, which restricts government activity to avoid unfairly influencing public opinion. This has hit two major consultations for the pharma industry—the Accelerated Access Review (AAR) and proposed changes to the medicines pricing system known as the Statutory Scheme. The AAR is the brainchild of life sciences minister George Freeman, who wants it to re-shape the U.K. market and the National Health Service (NHS) around encouraging medical innovation, and remove some of the blocks and bottlenecks which plague the current system.
The EMA has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).
OSE Pharma, an immuno-oncology company with a specific immunotherapy activating T lymphocytes, currently in a registration phase III study, and Effimune, a biotech company specialized in immune regulation with clinical applications in autoimmunity, transplantation and immune-oncology, have announce the signing of a proposed merger agreement.
JHL Biotech has received authorization from the U.K.s Medicines and Healthcare Products Regulatory Agency (MHRA) to begin clinical trials for JHL1101, a rituximab biosimilar developed and manufactured by its Taiwanese subsidiary to treat rheumatoid arthritis. JHL is the first company from the Greater China region to receive European approval for clinical trials of a monoclonal antibody biosimilar.
DNAtrix, a clinical stage, biotechnology company developing virus-driven immunotherapies for cancer, has announced its lead product, DNX-2401, has been designated by the European Commission as an Orphan medicinal product for the treatment of glioma. Glioblastoma, the deadliest form of glioma, strikes approximately 25,000 people a year in the U.S. and E.U.